Correction of Head Turn in Idiopathic Infantile Nystagmus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-05

Study Completion Date

2025-04-30

Brief Summary

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Infantile nystagmus is involuntary, bilateral, conjugate and rhythmic oscillations of the eyes which may present at birth or develop within the first 6 months of life. It may be idiopathic appearing without visual or neurological impairment or may be secondary to an afferent visual defect such as foveal hypoplasia, congenital cataract, retinal dystrophy or optic atrophy. Aiming at improving outcome of head turn in idiopathic infantile nystagmus, comparison between the efficacy and safety of graded Anderson procedure and Kestenbaum procedure is essential.

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Detailed Description

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Infantile nystagmus related abnormal head position is noted according to the axis, it can be anomalous horizontally (right or left head turn), vertically (chin up or down), torsionally (right or left head tilt) or in a mixed pattern. A head turn to right or left is the most common compensatory posture encountered in patients with infantile nystagmus with an eccentric null position. A prolonged head turn (HT) may interfere with the social interactions and the quality of life and may lead to skeletal deformities in the cervical spine with postural dysfunction and impaired movement pattern. Thus, the correction of an abnormal head turn is important to enlarge the visual field, to eliminate the possibility of abnormal contracture of the neck muscles and to permit an adequate vision.Various extraocular muscle surgeries have been advised to correct infantile nystagmus-related HT. Despite being the most common surgical technique used till today for correction of head turn related to nystagmus, Kestenbaum procedure has variable long- term results, limited success rate and involves four rectus muscles (recession/ resection). In graded Anderson procedure, only yoke muscle recession is done based on the amount of initial head turn leaving two untouched muscles.

Conditions

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Infantile Nystagmus Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The patients with infantilenystagmus related head turn are divided randomly in two groups according to the surgical procedure to be performed Group I (Graded Anderson procedure);Group II (Kestenbaum procedure)

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Group I (Graded Anderson procedure)

patients with idiopathic infantile nystagmus related head turn corrected by graded Anderson procedure.

Group Type ACTIVE_COMPARATOR

Graded Anderson procedure

Intervention Type PROCEDURE

In graded Anderson proceduren only recession of yoke muscles is done.

Group II (Kestenbaum procedure)

patients with idiopathic infantile nystagmus related head turn corrected by Kestenbaum procedure.

Group Type ACTIVE_COMPARATOR

Kestenbaum procedure

Intervention Type PROCEDURE

In Kestenbaum procedure, recession of yoke muscles and resection of their antagonists is done based on Parks table for Kestenbaum procedure according to the preoperative amount of head turn.

Interventions

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Graded Anderson procedure

In graded Anderson proceduren only recession of yoke muscles is done.

Intervention Type PROCEDURE

Kestenbaum procedure

In Kestenbaum procedure, recession of yoke muscles and resection of their antagonists is done based on Parks table for Kestenbaum procedure according to the preoperative amount of head turn.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Orthophoric Patients with idiopathic infantile nystagmus related head turn (≥20 degrees - ≤ 45 degrees) that is verified at least twice in two separate visits.

Exclusion Criteria

1. Patients with infantile nystagmus secondary to ocular diseases
2. Patients with infantile nystagmus with associated strabismus.
3. Previous squint, scleral buckling or glaucoma surgeries.
4. Associated systemic or neurological disorders.
5. Patients with anisometropia ≥ 5D.
6. Patients with nystagmus attenuated at near

Minimum Eligible Age

5 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No